Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT06231693
Eligibility Criteria:
Inclusion Criteria:
* Aged above 18 years old;
* Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer;
* Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line;
* Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.
Exclusion Criteria:
* Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms);
* Have other active neoplasms (except from non-melanoma skin tumors);
* Have serious or active non-oncology lung diseases;
* Have other primary and concurrent breast tumor with differing receptor profiles.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06231693
Study Brief:
Protocol Section:
NCT06231693